October 3, 2022


WASHINGTON — A shortage of vaccines to fight a fast-growing monkeypox outbreak was caused in part because the Department of Health and Human Services failed early on to request that the bulk stockpiles of the vaccine it already had for distribution be bottled, according to multiple administration officials. familiar with the subject.

By the time the federal government placed its orders, the vaccine’s Denmark-based maker, Bavarian Nordic, was booked with other customers and unable to do the work for months, officials said — even though the federal government had invested over $1 billion in vaccine development.

The government is now distributing about 1.1 million doses, less than a third of the 3.5 million that health officials now estimate are needed to fight the outbreak. He doesn’t expect the next delivery, of half a million doses, until October. Most of the other 5.5 million doses the United States has ordered are not scheduled to be delivered until next year, according to the federal health agency.

To speed up deliveries, the government is trying to find another company to take on some of the bottling, capping and labeling of the frozen bulk vaccine stored in large plastic bags at Bavarian Nordic’s headquarters outside Copenhagen. Because this final phase of construction, known as fill and finish, is highly specialized, experts estimate it will take another company at least three months to prepare. Negotiations are underway with Grand River Aseptic Manufacturing, a Michigan plant that helped produce Covid-19 vaccines, to bottle 2.5 million of the doses ordered, hopefully not months behind schedule, according to people familiar with the situation.

Health and Human Services officials so miscalculated the need that on May 23 they allowed Bavarian Scandinavia to deliver about 215,000 fully prepared doses that the federal government had already bought to European countries instead of keeping them for the United States.

At the time, the nation had only eight confirmed cases of monkeypox, agency officials said. And he couldn’t have used those doses right away because the Food and Drug Administration hadn’t yet certified the plant where the vaccine, Femalepoured into vials.

But he could now. Some states are trying to extend the doses by giving recipients only one shot of the two-dose vaccine. California, Illinois and New York have declared public health emergencies. In New York City, every available monkeypox shot slot is taken.

Lawrence O. Gostin, a former adviser to the Centers for Disease Control and Prevention who has advised the White House on monkeypox, said the administration’s response was hampered by “the same kinds of bureaucratic delays and forgetting and dropping the ball that we did during the Covid pandemic”.

Barriers to filling and finishing vials follow other mistakes that have limited vaccine supply. The United States once had about 20 million doses into a national stockpile, but failed to replenish them as they expired, leaving the supply to dwindle to almost nothing. It had 372,000 doses ready for circulation in Denmark, but waited weeks after the first case was identified in mid-May before ordering delivery of most of those doses. Another approximately 786,000 doses were held up by an FDA inspection at the manufacturer’s new filling and finishing plant, but have now been shipped.

The government also owns the equivalent of about 16.5 million doses of bulk vaccine produced and stored by Bavarian Nordic. But by the time the health service ordered 500,000 doses worth to be bottled on June 10, other countries with outbreaks had placed their own orders and the earliest delivery date was October.

Another order for 110,000 doses for European nations soon followed. When the United States returned with two more orders of 2.5 million doses each – announced on July 1 and July 15 – the volume could only be delivered next year.

Mr. Gostin, who now directs the O’Neill Institute for National and Global Health Law at Georgetown University, predicted that President Biden’s decision to appoint two new monkeypox coordinators would help “light a fire” under federal health services. The White House announced Tuesday that Robert Fenton, administrator at the Federal Emergency Management Agency, and Dr. CDC official Dimitris Daskalakis will lead the response.

Mr Gostin said the nation’s public health services were “asleep at the wheel” and the new co-ordinators should help “unblock all the barriers to the supply and delivery of vaccines and medicines, which has been deeply disappointing”.

Two senior federal officials, who spoke on condition of anonymity to speak candidly, said Mr. Biden is upset about the lack of a vaccine. His administration has often touted its success in providing hundreds of millions of coronavirus shots to Americans, and has faced criticism that a lack of foresight and management has left gay men — the primary risk group for monkeypox — unprotected.

Some critics blame a failure of leadership at the Department of Health and Human Services, saying the department’s secretary, Xavier Becerra, has taken a hands-off approach to an increasingly serious situation. His department not only oversees both the CDC and the Food and Drug Administration, but also runs the Biomedical Advanced Research and Development Authority, or BARDA, which helps develop and buy vaccines, tests and treatments to protect against highly contagious viruses, bioterrorism and other risks.

During a news conference on monkeypox last week, Mr. Becerra said his department was doing everything it could to ensure that “we not only stay ahead of this virus but that we end this outbreak ». He noted that he had recently elevated the agency’s Office of Strategic Preparedness and Response so it could respond more quickly to public health emergencies.

Sarah Lovenheim, its spokeswoman, said in a statement: “Our response has accelerated to meet evolving needs on the ground and will continue to accelerate. We will use every lever possible to continue to deliver tranches ahead of schedule as much as possible.”

So far, according to the CDC, 6,326 cases of monkeypox has been reported. At present, the virus is spread almost entirely among gay and bisexual men, and those with multiple or anonymous partners are considered particularly at risk. Mr. Becerra noted that while more than a million Americans have died from Covid-19, no one in the United States has died from monkeypox.

The official number of cases is widely believed to be an underestimate. Not only is testing limited, but public health officials like Dr. Joseph Kanter, the top medical official in Louisiana, said monkeypox can be difficult to diagnose. “It can be one or two isolated lesions, so if it’s not on a clinician’s radar,” he said, it can be missed.

With very few doses, health officials apparently plan to rely heavily on the “test and trace” strategy that figures heavily in the early stages of the Covid pandemic. As the pandemic escalated, the sheer flood of cases overwhelmed the ability of health officials to contact people who may have been infected by someone who had tested positive for the coronavirus. Once Covid vaccines became available, they became the cornerstone of the administration’s response to the pandemic.

By early June, Health and Human Services officials appeared firmly convinced that the United States had more than enough of the monkeypox vaccine, called Jynneos, to handle what appeared to be a handful of cases.

Bavarian Nordic was able to develop the vaccine, which also works against smallpox, thanks in large part to support from the federal government, which topped $1 billion in 2014 and now stands at $2 billion. Dawn O’Connell, assistant secretary for preparedness and response at the federal health agency, told reporters in early June: “People have Jynneos because we invested in it.”

The company opened a new $75 million filling and finishing plant in 2021 that now bottles up to 200,000 to 300,000 cases a week. At the time, the United States relied on Jynneos for protection against smallpox, not monkeypox, and the government had a large stockpile of another effective smallpox vaccine. No FDA inspection was scheduled until after the monkeypox outbreak and was not completed until July 27.

In early June, Health and Human Services officials agreed to effectively loan about 215,000 final doses of vaccine to Bavarian Scandinavia so the company could supply them to European countries suffering from outbreaks.

“It didn’t make sense while we were waiting for the FDA to complete the review – which is coming – to sit on doses that our international colleagues in Europe could actually use,” Ms O’Connell said on June 10. Now the government is trying to reschedule the delivery of those installments to later this year, a company spokesman said.

The final step of placing the liquid vaccine into vials represents a significant share of the cost of vaccine production. Some federal officials say the health department was slow to submit its orders for this project because BARDA officials claimed they were short of funds.

But when the demand for vaccines became an outcry, the agency found the money to pay for five million more doses to be bottled. Officials are now considering shifting half the work to another company that may be able to complete and fill batches more than twice as fast.

Some experts say it can take up to six to nine months to prepare a plant to handle a vaccine like Jynneos, which contains a live virus in an attenuated state. Carlo de Notaristefani, who oversaw the manufacturing of coronavirus vaccines for the federal government until last year, said such factories must operate at a high “biosafety level,” including a fully enclosed, segregated production line.

But he and other experts said it should be possible to streamline the transfer of the Bavarian Nordic process so that another plant would be ready in about three months. A company spokesman said Bavarian Nordic agreed to pay $10 million of the cost of such a transfer after federal officials said they did not have the budget for it.

Kitty Bennett contributed to the research.



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